Flt3L in Treating Patients With Metastatic Colorectal Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | March 4, 2013 | ||||
| Start Date ICMJE | June 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00003431 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Flt3L in Treating Patients With Metastatic Colorectal Cancer | ||||
| Official Title ICMJE | Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer | ||||
| Brief Summary | RATIONALE: Flt3L may stimulate a person's immune system and help kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of flt3L given to patients before undergoing surgery to remove metastases from colorectal cancer. |
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| Detailed Description | OBJECTIVES: I. Evaluate the safety and feasibility of administering flt3 ligand to patients with hepatic metastases from colorectal cancer prior to surgical resection. OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and metastasis resection. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter. PROJECTED ACCRUAL: This study will accrue 12 patients in 1 year. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: recombinant flt3 ligand | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | May 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed metastatic colon cancer expressing carcinoembryonic antigen (CEA) At least 50% of tumor cells must express CEA with at least moderate intensity Resectable hepatic metastases or other site of metastatic colon cancer that is resectable (e.g., lung metastases) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1000/mm3 Absolute lymphocyte count at least 1000/mm3 Hemoglobin at least 9 mg/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No ongoing cardiac disease No New York Heart Association class III or IV heart disease Pulmonary: No ongoing pulmonary disease such as: Asthma Chronic obstructive pulmonary disease (COPD) Active radiation- or drug-induced pneumonitis Other: Not pregnant or nursing Fertile patients must use effective contraception No history of autoimmune disease such as but not limited to: Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma Type I diabetes Multiple sclerosis No other serious ongoing chronic or acute illness No medical or psychological impediment to study compliance No concurrent or prior second malignancy except: Nonmelanoma skin cancer Controlled superficial bladder cancer within the last 5 years No active or chronic infection including: Urinary tract infection HIV Viral hepatitis PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other: No immunosuppressives such as: Azathioprine Cyclosporine A |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00003431 | ||||
| Other Study ID Numbers ICMJE | CDR0000066457, DUMC-98032, NCI-G98-1454 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Duke University | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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